The first US patient has been randomized in the pivotal i-SIGHT2 clinical trial evaluating the investigational i-Lumen AMD System for patients with intermediate to advanced dry age-related macular degeneration (AMD), i-Lumen Scientific announced.

The randomized, sham-controlled i-SIGHT2 trial is designed to evaluate the safety and effectiveness of the noninvasive, office-based bioelectric therapy in patients with vision loss due to dry AMD. The system delivers low-level microcurrent stimulation through the eyelid with the goal of increasing the transepithelial potential and repolarizing retinal pigment epithelium cells. The company said this approach is intended to restore retinal electrophysiologic signaling and improve photoreceptor function.

The pivotal study follows the company's completed i-SIGHT feasibility trial, in which treated eyes demonstrated improvements in visual function, retinal electrophysiology, and structural biomarkers associated with photoreceptor health. According to the company, those findings supported advancement to the pivotal study. RP